Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) voted to update the adult age-based pneumococcal vaccination guidelines and recommends CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for pneumococcal vaccination in adults 50 years of age and older..

默克（纽约证券交易所代码：MRK），在美国和加拿大以外被称为MSD，今天宣布，美国疾病控制与预防中心（CDC）免疫实践咨询委员会（ACIP）投票更新了成人年龄肺炎球菌疫苗接种指南，并推荐CAPVAXIVE™（肺炎球菌21价结合疫苗）用于50岁及以上成年人的肺炎球菌疫苗接种。。

The updated ACIP guidelines recommend a single dose of CAPVAXIVE for:

最新的ACIP指南建议单剂量CAPVAXIVE用于：

Adults 50 years of age and older who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown;

50岁及以上的成年人，以前没有接受过肺炎球菌结合疫苗或以前的疫苗接种史未知；

Adults 19-49 years of age with certain underlying medical conditions or other risk factors who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown;

19-49岁的成年人，具有某些潜在的医疗条件或其他危险因素，以前没有接受过肺炎球菌结合疫苗或以前的疫苗接种史未知；

Adults 19 years of age and older who have started their pneumococcal vaccine series with PCV13 (pneumococcal 13-valent conjugate vaccine) but have not received all recommended PPSV23 (pneumococcal 23-valent polysaccharide vaccine) doses.

19岁及以上的成年人已开始使用PCV13（肺炎球菌13价结合疫苗）接种肺炎球菌疫苗系列，但尚未接受所有推荐的PPSV23（肺炎球菌23价多糖疫苗）剂量。

Shared clinical decision-making is also recommended regarding use of a supplemental dose of CAPVAXIVE for adults 65 years of age and older who have completed their vaccine series with both PCV13 and PPSV23.

对于已完成PCV13和PPSV23疫苗系列的65岁及以上成年人，还建议共同进行临床决策，以使用补充剂量的CAPVAXIVE。

CAPVAXIVE is indicated for:

CAPVAXIVE用于：

Active immunization for the prevention of invasive disease and pneumonia caused by

主动免疫预防侵袭性疾病和肺炎

Streptococcus pneumoniae

肺炎链球菌

serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in adults individuals 18 years of age and older;

18岁及以上成年人的血清型3、6A、7F、8、9N、10A、11A、12F、15A、15B、15C、16F、17F、19A、20A、22F、23A、23B、24F、31、33F和35B；

Active immunization for the prevention of pneumonia caused by

主动免疫预防肺炎

S. pneumoniae

肺炎链球菌

serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older.

18岁及以上个体的血清型3、6A、7F、8、9N、10A、11A、12F、15A、15C、16F、17F、19A、20A、22F、23A、23B、24F、31、33F和35B。

CAPVAXIVE should not be administered to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid; see additional Select Safety Information below.

CAPVAXIVE不应用于对CAPVAXIVE的任何成分或白喉类毒素有严重过敏反应（例如过敏反应）史的个体；请参阅下面的其他选择安全信息。

The indication for the prevention of pneumonia caused by

预防由肺炎引起的肺炎的适应症

S. pneumoniae

肺炎链球菌

serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial..

血清型3、6A、7F、8、9N、10A、11A、12F、15A、15C、16F、17F、19A、20A、22F、23A、23B、24F、31、33F和35B根据调理吞噬活性（OPA）测量的免疫反应在加速批准下获得批准。是否继续批准该适应症可能取决于验证性试验中临床益处的验证和描述。。

“The CDC’s decision to lower the age-based vaccination recommendations to begin at age 50 has the potential to be a practice-changing milestone,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “This recommendation is a significant step forward in efforts to enhance equitable access and may improve vaccination rates.

默克研究实验室高级副总裁、全球临床开发负责人兼首席医疗官Eliav Barr博士说：“疾病预防控制中心决定降低50岁开始的年龄疫苗接种建议，这可能是一个改变实践的里程碑。”。“这项建议是朝着加强公平获取的努力迈出的重要一步，并可能提高疫苗接种率。

We’re pleased about this progress and thank the CDC for their commitment to addressing invasive pneumococcal disease and pneumococcal pneumonia in adults.”.

我们对这一进展感到高兴，并感谢CDC致力于解决成人侵袭性肺炎球菌疾病和肺炎球菌肺炎。”。

Based on national-level CDC data from 2018-2022, the serotypes covered by CAPVAXIVE are responsible for more cases of invasive pneumococcal disease (IPD) in adults compared to PCV20 (pneumococcal 20-valent conjugate vaccine). In adults 50 years of age and older, CAPVAXIVE covers the serotypes responsible for approximately 84% of IPD cases, compared to approximately 52% covered by PCV20.

。在50岁及以上的成年人中，CAPVAXIVE覆盖了约84%的IPD病例的血清型，而PCV20覆盖了约52%。

These values are based on CDC epidemiologic data and do not reflect the efficacy of the respective vaccines. There are currently no studies comparing the efficacy of CAPVAXIVE and PCV20. In certain at-risk adult populations in Alaska, Colorado, New Mexico, Oregon and the Navajo Nation, a higher prevalence of IPD caused by serotype 4, which is not included in CAPVAXIVE, has been reported.

。目前还没有比较CAPVAXIVE和PCV20疗效的研究。据报道，在阿拉斯加州，科罗拉多州，新墨西哥州，俄勒冈州和纳瓦霍族的某些高危成年人群中，由血清型4引起的IPD患病率较高，而CAPVAXIVE未包括在内。

IPD surveillance from other geographic areas in the U.S. has not detected significant percentages of serotype 4..

美国其他地理区域的IPD监测未发现明显百分比的血清型4。。

These provisional recommendations will be published on the CDC website following the meeting and will be official once reviewed and finalized by the director of the CDC and the Department of Health and Human Services.

这些临时建议将在会议后发布在疾病预防控制中心的网站上，并将在疾病预防控制中心主任和卫生与公众服务部审查并最终确定后正式发布。

Select Safety Information for CAPVAXIVE

为CAPVAXIVE选择安全信息

Do not administer CAPVAXIVE to individuals with a history of a severe allergic reaction (eg, anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid.

不要给有严重过敏反应（例如过敏反应）史的人服用CAPVAXIVE，因为CAPVAXIVE的任何成分或白喉类毒素都有严重的过敏反应。

Individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to CAPVAXIVE.

免疫活性改变的个体，包括接受免疫抑制治疗的个体，可能对CAPVAXIVE的免疫反应降低。

The most commonly reported (>10%) solicited adverse reactions in individuals 18 through 49 years of age who received CAPVAXIVE were: injection-site pain (73.1%), fatigue (36.0%), headache (27.5%), myalgia (16.4%), injection-site erythema (13.8%), and injection-site swelling (13.3%).

接受CAPVAXIVE治疗的18至49岁个体中最常报告的（>10%）引起的不良反应是：注射部位疼痛（73.1%），疲劳（36.0%），头痛（27.5%），肌痛（16.4%），注射部位红斑（13.8%）和注射部位肿胀（13.3%）。

The most commonly reported (>10%) solicited adverse reactions in individuals 50 years of age and older who received CAPVAXIVE were: injection-site pain (41.2%), fatigue (19.7%), and headache (11.0%).

接受CAPVAXIVE治疗的50岁及以上人群中最常报告的不良反应（>10%）是：注射部位疼痛（41.2%），疲劳（19.7%）和头痛（11.0%）。

Vaccination with CAPVAXIVE may not protect all vaccine recipients.

接种CAPVAXIVE可能无法保护所有疫苗接种者。

About CAPVAXIVE

关于CAPVAXIVE

CAPVAXIVE is Merck’s approved 21-valent pneumococcal conjugate vaccine indicated for active immunization for the prevention of invasive disease and pneumonia in adults 18 years of age and older. CAPVAXIVE is specifically designed to help address

CAPVAXIVE是默克公司批准的21价肺炎球菌结合疫苗，用于主动免疫，以预防18岁及以上成年人的侵袭性疾病和肺炎。CAPVAXIVE专门用于帮助解决

Streptococcus pneumoniae

肺炎链球菌

serotypes predominantly responsible for adult invasive pneumococcal disease (IPD), including eight unique serotypes, 15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B compared to other pneumococcal vaccines. CAPVAXIVE is administered as a single dose.

与其他肺炎球菌疫苗相比，主要负责成人侵袭性肺炎球菌病（IPD）的血清型包括八种独特的血清型，即15A，15C，16F，23A，23B，24F，31和35B。CAPVAXIVE以单剂量给药。

About Pneumococcal Disease

关于肺炎球菌疾病

Pneumococcal disease is an infection caused by a bacteria called

肺炎球菌病是由一种名为

Streptococcus pneumoniae

肺炎链球菌

. There are about 100 different types (referred to as serotypes) of pneumococcal bacteria, which can affect adults differently than children. Pneumococcal disease can be invasive or non-invasive. Non-invasive pneumococcal illnesses include pneumonia (when pneumococcal disease is confined to the lungs), whereas invasive pneumococcal illnesses include pneumococcal bacteremia (infection in the bloodstream), bacteremic pneumococcal pneumonia (pneumonia with bacteremia) and pneumococcal meningitis (infection of the coverings of the brain and spinal cord).

。大约有100种不同类型（称为血清型）的肺炎球菌，对成年人的影响与儿童不同。肺炎球菌疾病可以是侵袭性的或非侵袭性的。非侵袭性肺炎球菌疾病包括肺炎（当肺炎球菌疾病局限于肺部时），而侵袭性肺炎球菌疾病包括肺炎球菌菌血症（血流感染），菌血症性肺炎球菌肺炎（肺炎伴菌血症）和肺炎球菌脑膜炎（感染大脑和脊髓的覆盖物）。

Pneumococcal pneumonia is a type of bacterial pneumonia, which is the most common clinical presentation of pneumococcal disease in adults. It’s estimated that over 150,000 adults are hospitalized from pneumococcal pneumonia each year in the U.S..

肺炎球菌肺炎是一种细菌性肺炎，是成人肺炎球菌疾病最常见的临床表现。据估计，美国每年有超过150000名成年人因肺炎球菌肺炎住院。。

About Merck

默克

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines.

在美国和加拿大以外被称为MSD的默克公司，我们的目标是团结一致的：我们利用尖端科学的力量来拯救和改善世界各地的生活。130多年来，我们通过开发重要的药物和疫苗给人类带来了希望。

We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.

我们立志成为世界上领先的研究密集型生物制药公司，今天，我们处于研究的前沿，以提供创新的健康解决方案，促进人类和动物疾病的预防和治疗。我们培养了一支多元化和包容性的全球劳动力队伍，并每天负责任地运作，为所有人和社区创造一个安全、可持续和健康的未来。